Bone support device, system, and method

ABSTRACT

A bone support and/or barrier device, system, kit, and method can include an implantable structure having an outer surface, an inner surface, a first bone contact portion, and a second bone contact portion. The structure can be collapsible to an undeployed configuration capable of percutaneous insertion to the interior of a bone and expandable to a deployed configuration in the bone. In the deployed configuration, the first bone contact portion can contact a first portion of the bone, and the second bone contact portion can contact a second portion of the bone such that a load placed on the first portion of the bone can be transferred through the implantable structure to the second portion of the bone. The implantable structure can include a barrier material adapted to restrict a bone filler material inserted into the bone adjacent the inner surface of the structure from flowing to the outer surface of the structure.

FIELD OF THE INVENTION

The present invention relates to bone support and/or barrier devices andsystems, kits comprising a bone support and/or barrier device, andrelated methods. Embodiments of the present invention can beadvantageous for providing support and/or barrier to a bone accessed bya minimally invasive technique or other surgical technique.

BACKGROUND OF THE INVENTION

Bone may become fractured or prone to compression fracture or collapsedue to various conditions, including osteoporosis, avascular necrosis,cancer, trauma, or other disease. If not successfully treated, fracturedor weakened bone can result in deformities, chronic complications, andan overall adverse impact upon the quality of life.

Minimally invasive surgical procedures have been developed that can beused to treat fractured bones. Such minimally invasive procedures canreduce pain, post-operative recovery time, and the destruction ofhealthy tissue. In minimally invasive surgery, the site of pathology isaccessed through portals rather than through a significant incision,thus preserving the integrity of intervening tissues. These minimallyinvasive techniques also often require only local anesthesia.

Minimally invasive surgical techniques are particularly desirable forspinal and neurosurgical applications because of the need for access tolocations deep within the body and the danger of damage to vitalintervening tissues associated with conventional “open” accesstechniques. The development of minimally invasive spinal procedures, forexample, for repair of vertebral compression fractures, has resulted inreduced recovery time and decreased post-operative pain as suchprocedures require minimal, if any, muscle dissection and can beperformed under local anesthesia.

Minimally invasive procedures for reducing a vertebral compressionfracture (“VCF”) can include inserting a bone tamp, such as anexpandable balloon, curette, and/or other device into a vertebral body.The bone tamp can be used to create a void, or interior cavity, in thecancellous bone in the vertebral body. The void can be filled with afilling material, such as a bone cement, in order to provide interiorstructural support for cortical bone.

In certain applications, it may be desirable to provide structuralsupport to a bone structure after a void has been created inside thebone structure. For example, a bone tamp may be utilized to create avoid inside a vertebral body and displace an endplate of the vertebralbody to restore the height of the vertebral body. In certain clinicalsituations, it may be desirable to provide structural support to theendplate in order to maintain the position of the endplate after thebone tamp has been removed prior to injection of bone cement to fill thevoid.

In certain disease states, such as osteoporosis, vertebral bodies may beparticularly susceptible to VCF. Moreover, patients who have suffered aVCF may be at risk for additional VCFs. The occurrence or reoccurrenceof VCFs may be related to collapse of an endplate into the vertebralbody. Thus, in certain medical situations, it may be desirable toprovide structural support to the endplate of a vertebral body toprevent the endplate from collapsing. In clinical situations in whichthe height of a collapsed vertebral body has been restored, it may bedesirable to provide structural support to maintain the height of theendplate.

SUMMARY OF THE INVENTION

Embodiments of the present invention can provide bone support and/orbarrier devices and systems, kits comprising a bone support and/orbarrier device, and related methods. Some embodiments are useful forsupporting a bony structure in an interior body region in a human oranimal accessed utilizing minimally invasive surgery.

In an illustrative embodiment, the bone support device can comprise animplantable structure having an outer surface, an inner surface, a firstbone contact portion, and a second bone contact portion. A portion ofthe outer surface can comprise the first bone contact portion. Thestructure can be collapsible to an undeployed configuration capable ofpercutaneous insertion to the interior of a bone and expandable to adeployed configuration in the interior of the bone. In some embodiments,when the structure is in the deployed configuration, the first bonecontact portion can contact at least a first portion of the bone fromthe interior of the bone, and the second bone contact portion cancontact at least a second portion of the bone. In this manner, a loadplaced on the first portion of the bone can be transferred through theimplantable structure to the second portion of the bone. In certainembodiments, the device can be implanted in a vertebral body such thatthe first bone contact portion of the device can contact an endplate andthe second bone contact portion can contact cortical bone about aperimeter of the vertebral body, for example, the cortical bone in thevertebral body side wall.

In some embodiments, the bone support device can comprise a structurethat when deployed can extend between the superior endplate and theinferior endplate in a vertebral body. In this manner, a load placed onthe superior endplate can be transferred through the device to theinferior endplate to provide structural support to the superiorendplate. In certain embodiments, the bone support device can comprise astructure that when deployed can contact the endplate and both thecortical bone in the vertebral body side wall and the cortical bone inthe inferior endplate. Such a configuration can provide structuralsupport to the superior endplate by transferring a load from thesuperior endplate to both the vertebral body side wall and the inferiorendplate.

In some embodiments, the bone support device may be utilized to providestructural support to the interior of a bone without use of anyadditional support mechanisms, for example, injection of a bone cement.In other embodiments, the bone support device may be inserted into theinterior of a bone, and a bone cement can be injected into the boneinterior to provide further structural support to the bone.

In some embodiments, the implantable structure can include a barriermaterial attached to the structure that is adapted to prohibitsubstantially all of a bone filler material inserted into the boneadjacent the inner surface of the structure from flowing to the outersurface of the structure.

Other embodiments can comprise a system or a kit including animplantable bone support device having an outer surface, an innersurface, a first bone contact portion, and a second bone contactportion. The device can be releasably attached to the distal end of anelongate member, such as a deployment cannula, in an undeployedconfiguration. Such a system or kit can further include a deliverycannula having a hollow lumen that can be percutaneously inserted intothe interior of a bone. The elongate member and the attached bonesupport device may be inserted through the lumen of the delivery cannulato the bone interior.

A system or kit can further include a deployment mechanism that can beinserted through the lumen of the delivery cannula and actuated todeploy the bone support device into a deployed configuration in theinterior of the bone. In some embodiments, the system or kit can alsoinclude a release mechanism adapted to release the bone support devicefrom the elongate member. Some embodiments of a system or kit caninclude a plurality of the implantable bone support devices, in whicheach of the devices can be inserted into the interior of a bone anddeployed such that the deployed configurations support a separateportion of the bone.

Some embodiments of the present invention can comprise a barriermaterial that can be inserted into the interior of a bone and adapted toprohibit substantially all of a bone filler material inserted into thebone from flowing through and/or around the barrier material. Suchembodiments of a barrier material may prevent the undesirable flow ofthe bone filler material into and through a compromised portion of thebone. For example, an embodiment of a such a barrier material insertedinto a void created in the interior of a vertebral body may prevent theflow of subsequently injected bone cement through and/or around thebarrier material into a compromised endplate and/or vertebral body wall.In this manner, the barrier material may prevent leakage of the bonecement through the endplate and/or vertebral body wall. Such embodimentsof a barrier material may be utilized without any other structuralsupports.

Other embodiments can comprise a method for supporting a bone utilizingan implantable bone support device. The bone support device can comprisean outer surface, an inner surface, a first bone contact portion, and asecond bone contact portion. The device can be releasably attached tothe distal end of an elongate member in an undeployed configuration. Theelongate member and attached bone support device can be percutaneouslyinserted into the interior of a bone. In some embodiments, such a methodcan further include actuating a deployment mechanism to deploy the bonesupport device into a deployed configuration. Deploying the device intoa deployed configuration can cause the first bone contact portion tocontact at least a first portion of the bone from the interior of thebone, and the second bone contact portion to contact at least a secondportion of the bone. In this manner, a load placed on the first portionof the bone can be transferred through the device to the second portionof the bone. For example, in certain embodiments, the device can beimplanted in a vertebral body such that the first bone contact portionof the device can contact an endplate and the second bone contactportion can contact cortical bone about a perimeter of the vertebralbody, for example, the cortical bone in the vertebral body side wall.Some embodiments of a method may further include selectively positioningthe bone support device in a desired location and orientation in theinterior of the bone prior to, during, or after actuating the deploymentmechanism. In certain embodiments, a method can include releasing thebone support device from the elongate member. The elongate member maythen be removed from the bone. In some embodiments, such a method mayfurther include inserting an expandable body into the interior of abone, such as a vertebral body, and expanding the expandable body tocreate a void and/or move a collapsed or partially collapsed endplate soas to restore the height of the vertebral body.

Features of a bone support device, system, kit, and methods of thepresent invention may be accomplished singularly, or in combination, inone or more of the embodiments of the present invention. As will berealized by those of skill in the art, many different embodiments of abone support device, system, kit, and method for supporting a boneaccording to the present invention are possible. Additional uses,advantages, and features of embodiments of the invention are set forthin the illustrative embodiments discussed in the detailed descriptionherein and will become more apparent to those skilled in the art uponexamination of the following.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a bone support device system having animplantable structure attached to the distal end of an elongate memberinserted through a delivery cannula in an embodiment of the presentinvention.

FIG. 2 is an elevation (lateral) view of several human vertebrae, with adelivery cannula establishing a path to a vertebral body of one of thevertebrae.

FIG. 3 is a plan (coronal) view of a human vertebra being accessed by adelivery cannula, with portions of the vertebra removed to revealcancellous bone within a vertebral body.

FIG. 4 is a side view of a bone support device attached to the distalend of an elongate member and a handle having a deployment mechanismattached to the proximal end of the elongate member in an embodiment ofthe present invention.

FIG. 5 is a cross-sectional view of a vertebral body showing the bonesupport device in FIG. 4, pivoted toward an endplate in an embodiment ofthe present invention.

FIG. 6A is a cross-sectional view of a vertebral body showing the bonesupport device in FIG. 4, fully deployed in contact with an endplate andwalls of the vertebral body in an embodiment of the present invention.

FIG. 6B is a cross-sectional view of a vertebral body showing anembodiment of the bone support device having two sets of supportmembers, one set of support members fully deployed in contact with anendplate and walls of the vertebral body and the other set of supportmembers fully deployed in contact with both the superior and inferiorendplates, in another embodiment of the present invention.

FIG. 7 is a view of a bone support device comprising an implantableframe structure having an outer ring and cross-members in anotherembodiment of the present invention.

FIG. 8 is a cross-sectional view of a vertebral body showing a bonesupport device comprising a dome-shaped implantable frame structurehaving an outer ring and cross-members that is fully deployed in contactwith an endplate and walls of the vertebral body in an embodiment of thepresent invention.

FIG. 9 is a cross-sectional view of a vertebral body showing a bonesupport device comprising a flat-shaped implantable frame structurehaving an outer ring and cross-members that is fully deployed in contactwith an endplate and walls of the vertebral body in an embodiment of thepresent invention.

FIG. 10 is a plan (coronal) view of a human vertebra with portions ofthe vertebra removed showing a bone support device comprising asemi-circular-shaped implantable frame structure having an outer ringand cross-members that is fully deployed in contact with walls of thevertebral body in an embodiment of the present invention.

FIG. 11 is a side view of a bone support device comprising animplantable frame structure having an outer ring and cross-members in anelongated, undeployed configuration in an embodiment of the presentinvention.

FIG. 12 is a view of cross-members of a bone support device comprisingan implantable frame structure showing the cross-members havingpivotable intersections with other cross-members in an embodiment of thepresent invention.

FIG. 13 is a view of the cross-members in FIG. 12, in which thecross-members have been collapsed into an undeployed configuration bypivoting at the cross-member intersections in an embodiment of thepresent invention.

FIGS. 14A-C are plan (coronal) views of a human vertebra with portionsof the vertebra removed and showing a delivery cannula inserted into theinterior of the vertebral body using an extra-pedicular approach in anembodiment of the present invention. FIG. 14B shows a bone supportdevice delivered on the distal end of an elongate member through thedelivery cannula into the interior of the vertebral body. FIG. 14C showsthe delivery cannula retracted toward the extra-pedicular entry site inthe vertebral body wall and the bone support device being furtherdeployed in the interior of the vertebral body.

FIG. 15 is a perspective view of a bone support device comprising animplantable six-sided frame structure having pivotable joints in atleast some of the frame members in an embodiment of the presentinvention.

FIG. 16 is a cross-sectional view of a vertebral body showing the bonesupport device in FIG. 14, in a fully deployed configuration in contactwith an endplate and walls of the vertebral body in an embodiment of thepresent invention.

FIG. 17 is a view of the bone support device in FIG. 15, in which theframe members have been pivoted about the pivot joints into a collapsed,undeployed configuration in an embodiment of the present invention.

FIG. 18 is a cross-sectional view of a vertebral body showing a bonesupport device comprising a disc of material wrapped about an elongatemember in an undeployed configuration in an embodiment of the presentinvention.

FIG. 19 is a cross-sectional view of a vertebral body showing the bonesupport device in FIG. 18, in which the disc of material is partiallyunwrapped by expansion of an expandable body inside the disc in anembodiment of the present invention.

FIG. 20 is a cross-sectional view of a vertebral body showing the bonesupport device in FIG. 18, in a fully deployed configuration in contactwith an endplate and walls of the vertebral body in an embodiment of thepresent invention.

FIG. 21 is a flow chart illustrating a method for supporting a bone inan embodiment of the present invention.

FIGS. 22A-B are cross-sectional views of a vertebral body showing avertebral body access in the vertebral body wall in an embodiment of thepresent invention.

DETAILED DESCRIPTION

Embodiments of the present invention can provide bone support and/orbarrier devices, systems, and kits, and methods. Some embodiments areuseful for supporting a bony structure in an interior body region in ahuman or animal accessed utilizing a minimally invasive surgerytechnique. The devices, systems, kits, and methods can be adapted foruse in many suitable interior body regions, wherever the support,repair, and/or protection of one or more layers of tissue may berequired for a therapeutic or diagnostic purpose. The illustrativeembodiments are associated with devices, systems, kits, and methods usedto treat bones. Other embodiments may be utilized in other interior bodyregions or with other types of tissues.

As used in this specification and the appended claims, “proximal” isdefined as nearer to a point of reference such as an origin, a point ofattachment, or the midline of the body. As used in this specificationand the appended claims, “distal” is defined as farther from a point ofreference, such as an origin, a point of attachment, or the midline ofthe body. Thus, the words “proximal” and “distal” refer to, for example,direction nearer to and farther from, respectively, an operator (forexample, surgeon, physician, nurse, technician, etc.) who inserts amedical device into a patient, with the distal end, or tip, of thedevice inserted inside the patient's body. For example, the end of amedical device inserted inside the patient's body is the distal end ofthe medical device, while the end of the medical device outside thepatient's body is the proximal end of the medical device.

Referring now to the figures, FIG. 1 is a view of a system 10 accordingto an embodiment of the present invention comprising a bone supportand/or barrier device 13. The system 10 is configured to allow an userto deliver and/or deploy the bone support and/or device 13 in a targetedarea in an interior body region, such as the interior 33 of a bone. Thesystem 10 includes an implantable structure 30 attached to the distalend 16 of the elongate member 14 that is configured to be used, forexample, in a minimally invasive procedure for repairing a vertebralcompression fracture.

As shown in FIG. 1, the system 10 can comprise a delivery cannula 11having a proximal end and a distal end 12. The delivery cannula 11 maybe fabricated from a material selected to facilitate advancement androtation of the elongate member 14 movably disposed within a hollowlumen of the delivery cannula 11. The delivery cannula 11 can beconstructed, for example, using standard flexible, medical grade plasticmaterials, such as vinyl, polyamides, polyolefins, ionomers,polyurethane, polyether ether ketone (PEEK), polycarbonates, polyimides,and polyethylene tetraphthalate (PET). The delivery cannula 11 can beconstructed as a bi-layer or a tri-layer of one or more of thesematerials. The delivery cannula 11 can also comprise more rigidmaterials to impart greater stiffness and thereby aid in itsmanipulation and torque transmission capabilities. More rigid materialsuseful for this purpose include stainless steel, nickel-titanium alloys(such as Nitinol), and other metal alloys.

The embodiment of the system 10 shown in FIG. 1 comprises the elongatemember 14 movably disposed within the delivery cannula 11. The elongatemember 14 can be have a hollow lumen that allows for movement of aflowable material, for example, a liquid or a gas, through the elongatemember 14. The elongate member 14 may be made from a resilient inertmaterial providing torsion transmission capabilities, for example,stainless steel, a nickel-titanium alloy such as Nitinol, and othersuitable metal alloys. In other embodiments, the elongate member 14 maybe fashioned from a variety of suitable materials, such as a carbonfiber, a glass, or a flexible material, for example, as a plastic orrubber. In an embodiment comprising a flexible elongate member 14, theelongate member 14 may be formed, for example, from twisted wirefilaments, such as stainless steel, nickel-titanium alloys (such asNitinol), and other suitable metal alloys.

The elongate member 14 may include a handle 50, for example, as shown inFIG. 4, at its proximal end 15 to aid in gripping and maneuvering theelongate member 14. Such a handle 50 can be formed from a plastic orfoam material and secured about the proximal end 15 of the elongatemember 14. In some embodiments, the elongate member 14, and thereby theimplantable structure 30, may be in communication with a controller,such as a slide controller, a pistol grip controller (as shown in FIG.4), a ratcheting controller, a threaded controller, or any othersuitable type of controller that can be configured to permit a user ofthe system 10 to control the extent to which the implantable structureof the bone support device extends beyond the distal end 16 of theelongate member 14. Such a controller may permit a user of the system 10to manipulate the implantable structure 30, for example, to providerotational torque and thereby control rotation of the elongate member 14and the implantable structure 30.

Referring now to FIGS. 2 and 3, an elevation (lateral) view of severalhuman vertebrae 20 is shown, with the delivery cannula 11 establishing apercutaneous path along its elongated axis 52 to a vertebral body 21 ofone of the several vertebrae 20. The vertebral body 21 extends on theanterior (i.e., front or chest) side of the vertebrae 20. The vertebralbody 21 comprises an exterior formed from compact cortical bone 24.Cortical bone (24) is defined as bone consisting of, or relating to,cortex, or outer layer of a bony structure. The cortical bone 24encloses an interior volume of reticulated cancellous 25, or spongy,bone (also called medullary bone or trabecular bone).

Due to various traumatic or pathologic conditions, such as osteoporosis,a vertebral body 21 can experience a vertebral compression fracture(VCF). In such conditions, cancellous bone 25 can be compacted, causinga decrease in height of the vertebra 20. In a VCF in particular,vertebral height tends to be lost in the anterior region of thevertebral body 21. The user of the system 10 may utilize it to provide acavity, or void, within the vertebral body 21, and to restore height tothe vertebral body 21 lost when a fracture occurred.

The upper and/or the lower surface of a vertebral body 21 with which anintervertebral disc has contact is defined as a vertebral body endplate22. Each vertebral body 21 has a top, or superior, endplate 22 and abottom, or inferior, endplate 22. Vertebral body endplates 22 comprisecortical bone 24. The perimeters of the endplates 22 are reinforced dueto the generally perpendicular proximity to the cortical bone 24 in thewalls 23 of the vertebral body. However, the tissue inside the vertebralbody 21 is soft cancellous bone 25. As a result, the middle portion ofthe endplates 22 may not be well supported anatomically and may thus bethe most susceptible to deformation and collapse.

The vertebral body 21 is in the general shape of an oval disc. As FIGS.2 and 3 show, access to the interior volume of the vertebral body 21 canbe achieved, for example, by drilling an access portal through a rearside of the vertebral body 21 (a postero-lateral approach). The portalfor the postero-lateral approach enters at a posterior side of thevertebral body 21 and extends anteriorly into the vertebral body 21.Alternatively, access into the interior 33 volume of a vertebral body 21can be accomplished by drilling an access portal through one or bothpedicles 26 of the vertebra 20. This is known as a transpedicularapproach.

Some embodiments of the present invention, for example, the system 10can be configured to be used, for example, in a kyphoplasty procedure.Kyphoplasty is a minimally invasive surgical procedure for reducing avertebral fracture and restoring height to an injured or diseasedvertebra 20. In a kyphoplasty procedure, after a cavity is formed in avertebral body 21, a bone filler material can be introduced into theresulting cavity to provide increased height and stability to thevertebra 20.

Applications and uses of embodiments of the bone support and/or barrierdevices 13 can vary depending on various clinical factors. For example,some embodiments of bone support devices 13 and/or systems 10 of thepresent invention may be utilized to repair a fractured bony structurefrom the interior 33 of a bone. Alternatively, or in addition, someembodiments may be implanted as a preventative measure to help reducethe incidence of fractures in certain patients.

In some embodiments, the bone support and/or barrier device 13 may beimplanted into the interior of a bone alone. In other embodiments, thebone support and/or barrier device 13 may be implanted into the interiorof a bone in combination with a bone filler material. For example, theexpandable body 17, such as a balloon kyphoplasty bone tamp, may beutilized to create a void in the vertebral body 21. After the void iscreated, the bone support and/or barrier device 13 may be inserted intoand deployed in the vertebral body 13. Once the device 13 is in adesired position, a bone cement can be injected into the void to fillthe rest of the void.

In some clinical situations, expansion of the expandable body 17 maycreate enough lift to move the superior endplate 22 in relation to theinferior endplate 22, thereby restoring height to the collapsedvertebral body 21. However, once the expandable body 17 is removed, thesuperior endplate 22 may partially or completely collapse from itsrestored height. In such a situation, the bone support device 13 may beimplanted in the vertebral body 21 to maintain the restored height ofthe vertebral body 21.

In some embodiments, the bone support device 13 may be inserted into anddeployed in the interior of the vertebral body 21 along with theexpandable body 17 such that once height restoration is achieved and theexpandable body 17 is retracted from the vertebral body 21, the bonesupport device 13 can remain inside the vertebral body 21 to providesupport to the endplate 22. In other embodiments, once a void is createdand the height of the vertebral body 21 is restored, the expandable body17 can be removed from the vertebral body 21. After the expandable body17 is removed, the bone support device 13 can be inserted to theinterior of the vertebral body 21 through the same percutaneous path asthe expandable body 17. Once in a desired position inside the vertebralbody 21, the bone support device 13 can be deployed to maintain theendplates 22 in a position of restored height and prevent the endplates22 from migrated back towards each other. In such an embodiment, thebone support device 13 can be adapted to expand with a lifting force onthe endplates 22 sufficient to restore the height of the vertebral body21 between the endplates 22.

In some clinical situations, it may be desirable to avoid the use of abone filler material. Thus, in some embodiments, the bone support device13 may be deployed in the vertebral body 21 without injection of a bonefiller material, or cement. In other embodiments, once the bone supportdevice 13 is in position in the vertebral body 21, a bone fillermaterial may be injected into the vertebral body 21 to provide furtherstructural support to the endplates 22 and vertebral body 21.

In some embodiments, the bone support device 13 can be configured suchthat once deployed inside the vertebral body 21, it can transfer a load,or force, 34 exerted downward along the axis of the superior endplate 21towards the vertebral body walls 23, thereby supporting the superiorendplate 22. In other embodiments, the bone support device 13 can beconfigured such that once deployed inside the vertebral body 21, it cantransfer the load 34 exerted downward along the axis of the superiorendplate 22 towards the inferior endplate 22 and thus provide support tothe superior endplate 22. In still other embodiments, the bone supportdevice 13 can be configured such that once deployed inside the vertebralbody 21, it can support the superior endplate 22 by transferring anaxial load 34 exerted on the superior endplate 21 towards both thevertebral body walls 23 and the inferior endplate 22.

FIG. 3 shows a vertebra 20 being accessed by the system 10 according toan embodiment of the present invention. The vertebra 20 is shown withportions removed to reveal cancellous bone 25 within the vertebral body21. The user of the system 10 may slide the elongate member 14 andattached components axially, or lengthwise, along the elongated axis 52,within the delivery cannula 11 to deliver the components to the targetedtreatment site.

In a kyphoplasty procedure, or other vertebral body repair procedure,the elongate member 14 can have attached to its distal end 16 a devicefor creating a void, or cavity, in the cancellous bone 25 of thevertebral body 21. As shown in FIG. 3, the void-creating device can bean expandable body 17, such as an inflatable balloon, as shown in FIG.3. In some embodiments, other apparatus and methods can be used tocreate a void within a vertebral body 21 or other bony structure. Theuser may rotate the elongate member 14, and thereby the expandable body17, to position the expandable body 17 for selective expansion in thetarget treatment area.

After the expandable body 17 is moved beyond the distal end 12 of thedelivery cannula 11, the expandable body 17 may be expanded from acontracted state to an expanded state to provide a cavity within thecancellous bone 25. The expandable body 17 may be expanded by movementof a flowable material, for example, normal saline, through the hollowelongate member 14 and into the interior of the expandable body 17.Embodiments of an expandable body 17 can move the superior and/orinferior endplates 22 of a vertebral body 21 toward a more normalanatomical position to restore height. In this manner, the outerdimensions of the vertebral body 21 can be maintained an/or restored.Once a desired void has been created, the expandable body 17 may becontracted by withdrawing the flowable material out of the expandablebody 17 through the hollow lumen of the elongate member 14. The elongatemember 14 and the contracted expandable body 17 may then be withdrawnthrough the delivery cannula 11.

In a minimally invasive procedure, an embodiment of the bone supportand/or barrier device 13 can be inserted percutaneously to a treatmentsite in a collapsed, or closed, undeployed configuration. Once theundeployed bone support and/or barrier device 13 is in a desiredposition in the interior 33 of a bone, the device 13 can be expanded toa deployed configuration. The bone support and/or barrier device 13 canbe expanded, or deployed, to its deployed configuration with variousdeployment mechanisms. One such mechanism for deploying the bone supportand/or barrier device 13 from its undeployed configuration can be theexpandable body 17, which may be, for example, an inflatable balloon.

The expandable body 17 may be attached to the distal end 16 of theelongate member 14 and inserted through the lumen of the deliverycannula 11 to the target site. The expandable body 17 can then beexpanded, such as by inserting a flowable material through the hollowelongate member 14 and into the interior of the expandable body 17.Expanding the expandable body 17 inside the undeployed bone supportand/or barrier device 13 can cause the bone support and/or barrierdevice 13 to expand outwardly from its undeployed configuration into itsdeployed configuration. In addition, in some embodiments, expanding thebone support and/or barrier device 13 outwardly can cause the device 13to be moved to a desired position within a bony structure. In someembodiments, the bone support and/or barrier device 13 can be movedoutwardly by other deployment mechanisms, for example, a hydraulicmechanism, by mechanical actuation, or by other suitable mechanismsand/or interfaces.

In some embodiments of the present invention, the bone support and/orbarrier device 13 can be delivered to a target area, for example, in theinterior 33 of a bone, simultaneously with the expandable device 17. Insuch embodiments, the bone support and/or barrier device 13 can bedeployed with the expandable body 17 from a first, collapsed state orconfiguration to a second, expanded state or configuration in the targetarea. In other embodiments, a void can be created with the expandablebody 17 and the expandable body 17 removed. Then, the bone supportand/or barrier device 13 can be delivered through the delivery cannula11 to the target area and deployed with an expandable device 17 or otherdeployment mechanism.

After the expandable body 17 is removed, a material or filler, such as abone cement, may be used to fill the void provided by the system 10. Useof a filler material may be beneficial in certain treatment areas, forexample, in a vertebra 20 where the system 10 is used to restore heightto a vertebral body 21. Such a bone filler material can distribute anaxial load 34 (as shown in FIG. 6) transferred from the vertebral body21 surfaces to the hardened filler material, ultimately strengtheningthe spine.

Embodiments according to the present invention are not limited inapplication to human vertebrae 20, and may be used to provide support tobony structures within other parts of a living or non-living organism.In certain embodiments, the system 10 can be utilized in variouslocations within the human body, depending upon the treatment goals aswell as the anatomy of the targeted bone. For example, embodiments of abone support device 13 and/or system 10 may be utilized in the treatmentof areas within the body other than the vertebra 21, including, forexample, the ribs, the femur, the radius, the ulna, the tibia, thehumerus, the calcaneus, or the spine.

One illustrative embodiment of the bone support device is shown in FIGS.4-6B. As shown in FIG. 6A, the bone support and/or barrier device 13 cancomprise a deployed configuration having an arch, or dome, shape 44similar to the shape of an opened umbrella.

After the delivery cannula 11 has been percutaneously inserted to atarget area in an interior body region, such as in a vertebral body 21,the bone support and/or barrier device 13 can be delivered to the targetarea through the delivery cannula 11. As shown in FIG. 6A, the bonesupport and/or barrier device 13 can be pivotably attached in acollapsed, undeployed configuration to the distal end 16 of the elongatemember 14 and delivered through the delivery cannula 11 to the targetsite. In some embodiments, the handle 50 can be attached to the proximalend 15 of the elongate member 14 outside a patient's body. The handle 50can include a mechanism that can be used to deploy the bone supportdevice 13 into a deployed configuration.

The bone support and/or barrier device 13 may be delivered to a targetsurgical site using other access devices. For example, in someembodiments, the bone support and/or barrier device 13 can be deliveredinto a target bony structure using a conventional bone filler device(not shown). Alternatively, the bone support and/or barrier device 13may be attached to the distal end of a modified curette (not shown) anddelivered on the modified curette through the delivery cannula 11 to thetarget site.

As shown in the embodiments in FIGS. 4-6B, the implantable structure 30of the bone support and/or barrier device 13 can comprise a central rod40 pivotably attached about a pivot 43 to the distal end 16 of theelongate member 14. A plurality of support members 41 can be pivotablyattached to the distal end 42 of the central rod 40 such that thesupport members 41 can be extended outwardly in a circular pattern. Inthe deployed configuration, the plurality of outwardly extending supportmembers 41 can form an arch, or dome shape 44.

When used in a vertebral body repair procedure, the bone support and/orbarrier device 13 can be positioned in a desired location within thevertebral body 21, for example, in a void created in the center of thevertebral body 21 between the endplates 22. Once the bone support and/orbarrier device 13 is in position, a first deployment mechanism 51 in thehandle 50 can be actuated to pivot, or “cock,” the bone support device13, for example, approximately 90 degrees relative to the longitudinalaxis 52 of the elongate member 14 to point the distal end 42 of thecentral rod 40 toward an endplate 22. (See FIG. 5.) A second deploymentmechanism 53 in the handle 50 can then be actuated to extend the supportmembers 41 outwardly from the central rod 40 so as to deploy the device13 into its operative configuration. (See FIGS. 6A-B.) In someembodiments, the first (rod pivoting) deployment mechanism 51 can beactuated by partially depressing the trigger portion of the handle 50.The second (support member extending) deployment mechanism 53 may beactuated by further depressing the trigger portion of the handle 50.Other mechanisms for deploying the bone support and/or barrier device 13may be used. For example, ratcheted or spring-loaded mechanisms may beused to help deploy the bone support and/or barrier device 13. In someembodiments, the bone support and/or barrier device 13 can comprise ashape memory material that can facilitate deployment of the device.

Some embodiments of the bone support and/or barrier device 13 caninclude a mechanism to release the device 13 from the distal end 16 ofthe elongate member 14 after it has been deployed and positioned in adesired position in a vertebral body 21. For example, one end of thebone support and/or barrier device 13 can include threads and can bethreaded onto mating threads on the distal end 14 of the elongate member14. When the device 13 is in position, the elongate member 14 can berotated so as to “unscrew” the elongate member 14 from the bone supportand/or barrier device 13 and release the device 13 into the vertebralbody 21. In another embodiment, the bone support and/or barrier device13 can be fit snugly over the distal end 16 of the elongate member 14.When the device 13 is in position, the device 13 can be urged off theend 16 of the elongate member 14 by slightly retracting the elongatemember 14 such that the proximal edge of the device 13 contacts thedistal edge 12 of the delivery cannula 11, thus releasing the device 13into the vertebral body 21. Alternative release mechanisms adapted torelease the central rod 40 from the elongate member 14 can be employed.

Some embodiments of the bone support and/or barrier device 13 cancomprise an implantable structure 30 having an outer surface 31, aninner surface 32, a first bone contact portion 35, and a second bonecontact portion 36. As shown in the embodiments in FIGS. 6A-B, in itsdeployed configuration, the implantable structure 30 of the bone supportand/or barrier device 13 can be positioned so that the outer surface 31of the arch-shaped, outwardly extending support members 41 contacts thecenter, or near the center, of the endplate 22. That is, at least aportion of the outer surface 31 of the outwardly extending supportmembers 41 can comprise the first bone contact portion 35. When theouter surface 31 of the structure 30 is in contact with the endplate 22,the distal ends 42 of the outwardly extending support members 40 can bepositioned in contact with cortical bone 24 about the perimeter of thevertebral body 21. Thus, the distal ends 42 about a perimeter of theoutwardly extending support members 41 can comprise the second bonecontact portion 36 of the device 13.

With the outer surface 31 of the device 13 in contact with the endplate22 and the distal ends 42 of the support members 41 in contact with thevertebral body walls 23, the axial load 34 placed on the endplate 22,particularly in the center of the endplate 22, can be transferredthrough the device 13 to the stronger cortical bone 24 in the vertebralbody walls 23. As a result, the bone support device 13 can spread outthe load 34 on the endplate 22 and distribute it more evenly across alarger area and against more rigid structures (cortical bone 24) in thevertebral body 21. If the axial load 34 on the endplate 22 reaches anamount such that the endplate 22 begins to deform, the pressure againstthe bone support device 13 can cause the device 13 to place morespreading force on the support members 41. As the support members 41spread farther from the center of the device 13 in a flattening mannerdue to the load 34 transferred from the endplate 22, the perimeter ofthe device 13 can be pushed more tightly against the cortical bone 24,which can provide support against further deformation of the endplate22.

In some embodiments, the bone support and/or barrier device 13 can bepositioned in a vertebral body 21 to deploy, or expand, upwardly towarda superior endplate 22 or to expand downwardly toward an inferiorendplate 22. The elongate member 14 can be rotated to position the bonesupport and/or barrier device 13 so that it is oriented in either theupward or downward position. In other embodiments, the device 13 caninclude two or more sets of support members 41. One set of supportmembers 41 can be deployed upwardly into contact with the superiorendplate 22, and another set of support members 41 can deployeddownwardly into contact with the inferior endplate 22.

In other embodiments, each of a plurality of bone support devices 13 canbe adapted in the deployed configuration to support a separate portionof the bone. For example, a first bone support device 13 can be insertedinto a vertebral body 21 and deployed into contact with one endplate 22.Following deployment of the first bone support device 13, a second bonesupport device 13 can be inserted into the vertebral body 21 anddeployed into contact with the opposite endplate 22.

Some embodiments of a bone support device 13 of the present inventioncan provide support or protection to an endplate 22 that may be weakeneddue to a disease process, for example, increased porosity due toosteoporosis. Such a weakened endplate 22 may be reinforced in themiddle portion of the endplate 22 and thus help protect against possiblevertebral compression fractures. In other embodiments, the bone supportdevice 13 can provide support to an already compromised anatomicalstructure, such as a vertebral body endplate 22, while an adjacent voidis being created, during reconstruction of nearby structures, and/orwhile a bone filler material is inserted and cured in the void.

In some embodiments, the bone support and/or barrier device 13 can beutilized in combination with a bone filler material that can be insertedinto a vertebral body void adjacent the device 13. In some embodiments,the bone filler material, or cement, can provide structural supportadjacent the bone support and/or barrier device 13 for protecting theintegrity of the vertebral body 21. Alternatively, the bone supportdevice 13can be utilized without a bone filler material.

The bone support device 13 can be made from various surgical materialssuitable for use in an interior body region. For example, the bonesupport device 13 can be made from materials such as titanium, a shapememory material such as Nitinol, stainless steel, and/or polymers thatare sufficiently strong to support a bony structure. In variousembodiments, the bone support device 13 can have a thickness sufficientto provide desired load support to an endplate 22 to prevent deformationor collapse of the endplate 22. For example, the device 13, includingthe support members 41, can have a thickness in the range of about 1-5mm. The desired thickness of the device material can depend on a numberof factors, including, for example, whether the device 13 is to bepermanently implanted, whether a bone filler material is to be used withthe device 13, whether the device 13 has a lateral dimension sufficientto span an entire endplate 22 or less than the entire endplate 22, etc.

In some embodiments, the bone support and/or barrier device 13 can havea barrier material 37, for example, as shown in FIG. 6, connecting thesupport members 41. Such a span of barrier material 37 can provideadditional support to an endplate 22 or other bony structure. Thebarrier material 37 can be adapted to prohibit substantially all flow ofbone filler material from the inner surface 32 of the deployed device 13to the outer surface 31 of the device 13. In this manner, the device 13can help prevent leakage of bone filler material through a compromisedbone adjacent the device 13. The barrier material 37 can compriseTeflon® (polytetrafluoroethylene), Dacron®, or other implantable,biocompatible material. In an embodiment, the barrier material 37 cancomprise an open weave pattern adapted to reduce, but not necessarilystop, the flow of bone filler material from the inner surface 32 to theouter surface 31 of the device 13.

In certain embodiments, the barrier material 37 can have a porositysufficient to allow nutrients to diffuse through the material 37 so asto reach the interior of the vertebral body 21. Alternatively, thebarrier material 37 can be a biodegradable material that can provideadditional support to an endplate 22 for a limited period of time, afterwhich the material degrades and is absorbed into surrounding tissue.Such a biodegradable material can include nutrients that can promotebone growth.

In some embodiments, the barrier material 37 can be a solid tubularmaterial, for example, a thin polymeric elastic material such as latex,placed about the exterior of the support members 41. In an alternativeembodiment, the barrier material 37 can be sheet material, such assheets of a thin polymeric elastic material, attached and sealed toadjacent support members 41. The barrier material 37 can be attachedbetween each pair of adjacent support members 41, or between less thaneach pair of adjacent support members 41. The barrier material 37 can beattached to the device 13 by, for example, sealing the material 37 tothe support members 41 with radio frequency or laser sealing or by othersuitable mechanisms.

In an embodiment, the barrier material 37 may comprise a nanocompositeplastic material. Nanocomposites include a resin matrix and a nano-sizedreinforcing filler material. Commercially available nano-fillers includeclays, silicas, and ceramics. Nanocomposites and nano-fillers areavailable commercially from the Foster Corporation, Putnam, Conn. Thesefillers are small enough to improve the strength of the resin matrix soas to provide a strong barrier material 37, while allowing the material37 to be extruded as a thin structure.

Some embodiments of the bone support and/or barrier device 13 can beshaped and sized to fit a void created in the interior of a bone. Incertain embodiments, the bone support and/or barrier device 13 can besized so as to span across substantially all of an endplate 22 when in afully expanded configuration. Alternatively, the bone support and/orbarrier device 13 can be sized to span less than substantially all of anendplate 22 when fully expanded. For example, the fully expanded device13 can be sized to cover approximately half or approximately one-thirdof the lateral dimensions of an endplate 22. Such smaller embodiments ofthe bone support device 13 can be used individually to provideprotection to a particular portion of an endplate 22. Alternatively, aplurality of embodiments of the bone support and/or barrier device 13having expanded, or deployed, dimensions less than that of the lateraldimensions of an endplate 22 can be used together to provide protectionfor the entire endplate 22. It may be desirable to use embodiments ofbone support and/or barrier devices 13 having less than the fulldimensions of an endplate 22 when access for delivery of a larger bonesupport device 13 to the vertebral body 21 may be difficult. Rather thanattempting to insert one larger bone support and/or barrier device 13,two smaller bone support and/or barrier devices 13 may be inserted, forexample, one device 13 through each pedicle of a vertebra 20 or via adifferent surgical approach.

The embodiment of the bone support device 13 in FIGS. 5 and 6 can havevarying vertical dimensions, or heights, when in its fully deployedconfiguration. For example, the bone support device 13 can have a domedor arched configuration 44 such that the height at least initiallygradually decreases from the center of the support members 41 toward theperimeter of the support members 41. As pressure from the endplate 22 istransferred to the device 13, the height at the center of the device 13can decrease as the support members 41 spread out to a larger anglerelative to the central rod 40. In another embodiment, the bone supportdevice 13 can have an initial fully deployed configuration that isessentially flat about the entire lateral dimension of the device 13.

FIG. 6B illustrates an alternative embodiment of the bone support device13 shown in FIG. 6A. As shown in the embodiment in FIG. 6B, theumbrella-shaped bone support device 13 can include the first set ofsupport members 41 as described herein and a second set of supportmembers 46. When the bone support device 13 is in its deployedconfiguration, the second set of support members 46 can extend downwardfrom the distal end 42 of the central rod 40 at a more acute angle thanthe first set of support members 41. The second set of support members46 can extend the entire distance between the superior endplate 22 andthe inferior endplate 22 in the interior of the vertebral body 21. Withthe outer surface 31 of the bone support device 13 in contact with oneof the endplates 22, for example, the superior endplate 22, and thedistal ends 42 of the first set of support members 41 in contact withthe vertebral body walls 23, the axial load 34 placed on the superiorendplate 22 can be transferred through the device 13 to the strongercortical bone 24 in the vertebral body walls 23. In addition, with thedistal ends 42 of the second set of support members 46 in contact withthe opposite, inferior endplate 22, the load 34 placed on the superiorendplate 22 contacting the outer surface 31 can be transferred throughthe device 13 to the stronger cortical bone 24 in the inferior endplate22. As a result, the bone support device 13 can spread out the load 34on the first endplate 22 and distribute it more evenly across a largerarea and against more rigid structures (cortical bone 24) in thevertebral body 21.

Another embodiment of the bone support device 13 is shown in FIGS. 7-13.In such an embodiment, the bone support device 13 can comprise animplantable structure 30 comprising a frame 60 having an outer ring 61and a series of cross-members 62 each extending from one point on theouter ring 61 to another, generally opposite point on the ring 61. Theconfiguration of the outer ring 61 and the cross-members 62 can form anopen weave, or grid, pattern. An open weave pattern has the advantage ofallowing nutrient transfer to the adjacent intervertebral disc.

One side of the grid of cross-members 62 can comprise the outer surface31 of the implantable structure 30, and the opposite side of the grid ofcross-members 62 can comprise the inner surface 32. The outer surface 31of the cross-members 62 can comprise the first bone contact portion ofthe device 13 that can contact a first bone portion in the interior of abone, for example, an endplate 22 in a vertebral body 21. The outer ring61 can comprise the second bone contact portion that can contact asecond bone portion, for example, cortical bone 24 about the perimeterof the vertebral body 21. In this manner, a load 34 placed on the firstportion of the bone can be transferred through the implantable structure30 to the second portion of the bone, thereby supporting the first boneportion.

Embodiments of the bone support device 13 having the outer ring 61 and agrid of cross-members 62 can have various configurations. For example,as shown in FIG. 7, the outer ring 61 can have a circular or oval shape65. In some embodiments, the bone support device 13 comprising the outerring 61 and a grid of cross-members 62 can be configured to have anarched “dome” shape 66, as shown in FIG. 8, when the device 13 isdeployed inside an internal body region. Such a dome shape 66 can aid inthe transfer of the axial load 34 from the endplate 22 by providing abiased contact between the arched outer surface 31, or convex surface63, of the cross-members 62 and the endplate 22. In addition, such adome shape 66 can allow the perimeter of the outer ring 61 to engagecortical bone 24 along the vertebral walls 23 in a biased manner. As aresult, the load 34 can be transferred from the supported endplate 22 tocortical bone 24 in another vertebral body structure so as to provide agreater resistance to the load stress in the endplate 22. In anembodiment in which the outer ring 61 does not initially engage one ormore surfaces of the vertebral walls 23, as pressure from the endplate22 is exerted on the upper, convex surface 63 of the cross-members 62,the remainder of the device 13 may spread outwardly toward and intocontact with cortical bone 24 in the walls of the vertebral body 21. Inthis manner, support from the cortical bone 24 in the vertebral bodywalls 23 can stop further inward movement of the endplate 22. Thetransfer of load stress from the endplate 22 can help protect theendplate 22 from undergoing a compression fracture or from experiencingextension of an existing fracture.

Another embodiment of the bone support device 13 comprising the outerring 61 and cross-members 62 can have an essentially flat configuration67, as shown in FIG. 9. In such an embodiment, the device 13 can bedelivered into the vertebral body 21 and deployed so as to be positionedinto contact with both an endplate 22 and cortical bone 24 in the walls23 of the vertebral body 21. That is, the device 13 may be deployed intodirect contact with the endplate 22 without further positioning (such asrotating approximately 90 degrees as with the embodiment shown in FIGS.4-6). In such a flat configuration 67, load pressures 34 exerted on theendplate 22 can be transferred through the structure of the device 13 tothe cortical bone 24 in the vertebral body walls 21.

In another embodiment, as shown in FIG. 10, the outer ring 61 can be inthe shape of a semi-circle 68 with one side of the semi-circle 68 beinga flat portion of the outer ring 61 and the remainder of the semi-circle68 being an arcuate, circumferential edge connected to the ends of theflat portion of the outer ring 61. In this configuration, thecross-members 62 can extend from the flat side of the outer ring 61 tothe arcuate, circumferential edge of the outer ring 61. A semi-circularconfiguration 68 may be advantageous for conforming to the interior ofcertain bony structures, such as a vertebral body 21.

Some embodiments of the bone support device 13 comprising the outer ring61 and cross-members 62 can have other configurations that are suitablefor displacing axial load pressures 34 on an endplate 22 to other bonystructures (such as cortical bone 24). The design, shape, orconfiguration of the bone support device 13 comprising the outer ring 61and cross-members 62 can vary depending on a number of factors,including, for example, the type of anatomical structure intended forsupport and protection, the materials used to make the device 13, thetype of deployment apparatus, the location of the target site, whetheraccess to the target site is via open surgery or by minimally invasivetechniques, and others.

In certain embodiments, the bone support device 13 comprising the outerring 61 and cross-members 62 can be sized so as to span acrosssubstantially all of an endplate 22 when in a deployed configuration.Alternatively, the bone support device 13 can be sized to span less thansubstantially all of an endplate 22 when fully deployed. In someembodiments, a plurality of the bone support devices 13 can be usedtogether to provide support to particular portions of the endplate 22 orother bony structure(s).

In some embodiments, the bone support device 13 can be delivered intothe interior of the vertebral body 21 through various locations in thevertebral body wall 23 relative to the endplate 22. For example,embodiments of the bone support device 13 can be delivered into thevertebral body 21 interior at a location in the vertebral body wall 23near the endplate 22 such that the bone support device 13 can bedeployed adjacent the endplate 22. As shown in FIGS. 22A and 22B, incertain embodiments, a vertebral body access 27 can be made in thevertebral body wall 23 near the endplate 22. The delivery cannula 11 canbe inserted through the vertebral body access 27, and the bone supportdevice 13 can be delivered through the delivery cannula 11 into theinterior of the vertebral body 21.

When the vertebral body access 27 is located in the vertebral body wallnear the endplate 22, as shown in FIGS. 22A and 22B, the bone supportdevice 13 can be delivered into the vertebral body 21 interior in aposition adjacent the endplate 22. In certain embodiments, the bonesupport device 13 may be delivered through the vertebral body access 27such that the bone support device 13 can be positioned in contact withboth the endplate 22 and cortical bone 24 in the walls 23 of thevertebral body 21. That is, the device 13 may be deployed into directcontact with the endplate 22 without further positioning. As shown inFIGS. 22A and 22B, the dimensions of the vertebral body access 27 canvary. For example, the vertebral body access 27 may extend along themajority of the lateral side of the vertebral body 21, as in theembodiment in FIG. 22A. In another embodiment, the vertebral body access27 may extend along a shorter portion, for example, less than half, ofthe lateral side of the vertebral body 21, as in the embodiment in FIG.22B.

Embodiments of the bone support device 13 comprising the outer ring 61and cross-members 62 can comprise various materials, including, forexample, shape memory materials such as Nitinol or shape-memoryplastics. The bone support device 13 can comprise materials that impartsuitable rigidity to provide structural support to the target bonystructure.

In some embodiments, the bone support and/or barrier device 13comprising an outer ring and cross-members can have a barrier material37, for example, as shown in FIGS. 7, 8, and 10, connecting thecross-members 62. Such a span of barrier material 37 may provideadditional support to an endplate 22 or other bony structure. Thebarrier material 37 can be adapted to prohibit substantially all flow ofbone filler material from the inner surface 32 (such as the innerconcave surface of the dome-shaped device in FIG. 8) of the deployeddevice 13 to the outer surface 31 of the device 13. In this manner, thedevice 13 can help prevent leakage of bone filler material through acompromised bone adjacent the device 13. In an embodiment, the barriermaterial 37 can comprise an open weave or mesh design adapted to reduce,but not necessarily stop, the flow of bone filler material from theinner surface 32 to the outer surface 31 of the device 13. In such anembodiment, the bone barrier device can reduce the flow of bone fillermaterial from the inner surface 32 to the outer surface 31 of the device13, while allowing the flow of some bone filler material through thebarrier material 37, which can contact and bond with a bony structureadjacent the outer surface 31 of the device 13. In yet anotherembodiment, the bone support and/or barrier device 13 can includethrough holes in either the cross-members 62 or the barrier material 37,or both, so that the bone filler material can penetrate through thedevice 13 to fill the space in the void both adjacent the inner surface32 and adjacent the outer surface 31 of the device 13.

Some embodiments of the bone support device comprising an outer ring andcross-members can be inserted into an interior body region such as avertebral body via a minimally invasive technique. For example, thedelivery cannula 11 having a hollow lumen can be percutaneously insertedto the interior of a vertebral body. The bone support device 13 can bereleasably attached in an undeployed configuration to the distal end 16of the elongate member 14. The elongate member 14 and the attached bonesupport device 13 can be inserted through the lumen of the deliverycannula 11 into the vertebral body. When the bone support device 13 isin a desired position in the vertebral body, the device can be deployedinto a deployed configuration into contact with the endplate, vertebralbody walls, and/or other bony structures in the vertebral body. Then,the bone support device 13 can be released from the elongate member 14,and the elongate member 14 and delivery cannula 11 removed from thevertebral body.

Some embodiments of the bone support device 13 comprising an outer ringand cross-members can be collapsed from a deployed, or expanded,configuration to an undeployed, or collapsed, configuration have ageometry sized and shaped so as to fit through the lumen of the deliverycannula 11.

In some embodiments, the cross-members 62 can be configured to extend indifferent directions relative to other cross-members 62. For example, insome embodiments, as shown in FIGS. 7, 8, 10, and 11, the cross-members62 can be configured to extend from one position to another position onthe outer ring 61 in a substantially parallel relationship 69 to eachother. In other embodiments, for example, as shown in FIGS. 12 and 13,the cross-members 62 can be configured to extend so as to intersect withother cross-members 62 and form an open weave pattern. The cross-members62 can be configured in any pattern suitable for providing structuralsupport to a bony structure, such as a vertebral body endplate 22, andthat is amenable to being percutaneously inserted into an interior bodyregion in an undeployed, or collapsed, configuration.

In one embodiment, as shown in FIG. 11, the bone support device 13comprising the outer ring 61 and cross-members 62 can be extended, or“stretched,” along its longitudinal axis so as to form a more narrow,elongated configuration 71 that can be inserted through the deliverycannula 11. FIGS. 12 and 13 show another embodiment of a cross-memberdesign, in which the cross-members 62 can have an expanded, deployedconfiguration in which the cross-members 62 are aligned at approximatelyright angles relative to each other in an open weave, or “X-shaped”pattern. The cross-members 62 can be pivotably connected atintersections 72 at which they cross. By mechanically pulling on theends of the cross-members 62, the cross-members 62 can be pivoted aboutthe intersections 72 such that the cross-members 62 can collapse to anearly parallel relationship 69. FIG. 13 shows the cross-members 62 inan intermediate position between a deployed configuration as in FIG. 12and a fully collapsed, undeployed configuration. In this manner, thebone support device 13 having the outer ring 61 and cross-members 62 canbe collapsed into an undeployed configuration so as to fit through thelumen of the delivery cannula 11 for insertion into an interior bodyregion. Once the bone support device 13 is inserted into the interiorbody region, such as the vertebral body 22, a force can be exertedagainst at least one of the ends of the collapsed cross-members 62 so asto mechanically push, or expand, the cross-members 62 back into theiroriginal deployed configuration.

Expansion of the bone support and/or barrier device 13 from anundeployed configuration to a deployed configuration may be facilitatedby using a shape memory material, such as Nitinol or shape-memoryplastics, in the device 13. When the device 13 is in a desired positionin a vertebral body 22, heat from the patient's body can cause the shapememory material to deploy into its expanded deployed configuration.

In some embodiments, the implantable bone support and/or barrier device13 can be delivered to the interior of the vertebral body 21 by atrans-pedicular approach, as shown in FIGS. 5-6, 8-10, 15, and 17-19. Inan alternative embodiment, as shown in FIGS. 14A-14C, the bone supportand/or barrier device 13 can be delivered to the interior of thevertebral body 21 by an extra-pedicular approach. As shown in FIG. 14A,in an extra-pedicular approach, the delivery cannula 11 may be insertedinto and positioned within the vertebral body 21 from a position lateralto one of the vertebral body pedicles 26. As an example, FIG. 14Billustrates the delivery cannula 11 in place in the vertebral body 21using an extra-pedicular approach. The elongate member 14 can beinserted through the delivery cannula 11 such that the bone supportand/or barrier device 13 attached to the distal end 16 of the elongatemember 14 can be deployed inside the vertebral body 21. The embodimentof the bone support and/or barrier device 13 illustrated in FIGS. 14Band 14C is the embodiment of the device 13 comprising the frame 60having the outer ring 61and the cross members 62 shown in FIGS. 7, 8,and 11. As shown in FIG. 14B, the bone support device 13 can have theelongated configuration 71 while being inserted through the deliverycannula 11, and may be extended beyond the distal end 16 of the deliverycannula 11 into the interior of the vertebral body 21. As the deliverycannula 11 is retracted from its previous position shown in FIG. 14B,toward the vertebral body wall 23, as shown in FIG. 14C, the bonesupport device 13 may be fully extended beyond the delivery cannula 11such that the device 13 can be positioned into a fully deployedconfiguration. The bone support device 13 may be fully deployed invarious manners, such as using a mechanical deployment mechanism, forexample, the deployment mechanism actuated by the handle 50 shown inFIG. 4, or by self-deploying mechanisms, for example, as may befacilitated with the use of shape-memory material(s) in the device 13.The bone support device 13 shown in FIGS. 14A-14C delivered into theinterior of the vertebral body 21 may be fully deployed into aconfiguration similar to that shown in FIG. 8.

An extra-pedicular insertion approach may be useful for delivery of thebone support and/or barrier device 13 having dimensions that require arelatively large percutaneous insertion path into the vertebral body 21.For example, in some surgical procedures in which only an expandablebody such as a balloon is inserted into the vertebral body 21, thedelivery cannula 11 may be relatively small and the percutaneousinsertion path can likewise be relatively small. A trans-pedicularinsertion approach may accommodate such a relatively small deliverycannula 11. For procedures that include implanting an embodiment of thebone support and/or barrier device 13, the delivery cannula 11 may needto be larger than the delivery cannula 11 required for delivering onlyan expandable body. In such procedures, a trans-pedicular approach maynot be desirable for inserting such a larger delivery cannula 11.Accordingly, an extra-pedicular insertion approach may betteraccommodate insertion of a relatively larger delivery cannula 11 (andbone support and/or barrier device 13, for example) into the interior ofthe vertebral body 21. In addition, an extra-pedicular approach mayallow insertion of the bone support and/or barrier device 13 in aposition closer to and/or more closely aligned with, the endplate 22,for example, as shown in FIG. 9.

As shown in FIGS. 11, 17, and 18, the bone support and/or barrier device13 can include one or more radiopaque markers 70 that can be visualizedunder fluoroscopy. Radiopaque is defined as being opaque to radiationand especially x-rays. Fluoroscopy is defined as examination by means ofa fluoroscope. A fluoroscope is a device equipped with a fluorescentscreen on which the internal structures of an optically opaque object,such as the human body, may be viewed as shadowy images formed by thedifferential transmission of x-rays through the object.

The radiopaque markers 70 can be arranged in a radiopaque markingpattern that can be configured to allow for radioscopically visualizingthe positioning and orientation of the device 13 in the interior bodyregion during deployment. As a result, a non-radiopaque contrast mediumcan be used, for example, to expand the expandable body 17, therebyeliminating the risk of exposing a patient to a radiopaque contrastagent.

In some embodiments, the radiographic marking pattern can provideessentially an outline of the shape of the bone support and/or barrierdevice 13 when expanded. Thus, in addition to fluoroscopicallymonitoring the bone support and/or barrier device 13 as it is beingdeployed, when the device 13 is expanded to its deployed configuration,the periphery of the device 13, and thereby the outer contact points ofthe bone support and/or barrier device 13 onto tissue in the interiorbody region can be visualized radioscopically.

In some embodiments of the present invention, in addition to the bonesupport and/or barrier device 13, at least a portion of the deliverycannula 11, elongate member 14, and/or expandable body 17 may compriseone or more radiographic material(s) and/or markers 70. In this manner,positioning of the components used to deliver and deploy the bonesupport and/or barrier device 13 can be visualized radioscopicallyduring use. As such, the user can monitor positioning of the entire bonesupport device system 10 and any differences in positioning of onecomponent relative to the other component.

Radiopaque markers 70 can be made from radiopaque materials. Examples ofradiopaque materials include stainless steel, platinum, gold, calcium,tantalum, barium sulfate, tantalum, tungsten, bismuth subcarbonate, andother metals.

FIGS. 15-17 illustrate another embodiment of a bone support and/orbarrier device 13. As shown in this embodiment, the device 13 can beconfigured to guide and or control the distribution of bone fillermaterial injected into the interior of a bone. In some embodiments, thebone support and/or barrier device 13 can comprise an implantable sheetof barrier material 37 having six sides comprising a top 81, a bottom82, and four rounded faces 83, as shown in FIGS. 15-17. The faces 83 canbe generally perpendicular to the top 81 and the bottom 82 of the sheetof material 37.

The six-sided sheet of barrier material 37 can have the appearance of arounded cube-like structure. The rounded nature of the top 81, bottom82, and faces 83 of the sheet of barrier material 37 allows the sheet ofbarrier material 37 to more closely fit the contours of a void createdinside a bony structure, such as a vertebral body 21. In its deployedconfiguration, the outer surfaces 31 of the top 81 and bottom 82 of thesheet of barrier material 37 may be positioned into contact withselected portions of the interior of the bone, for example, the superiorand inferior endplates 22 in a vertebral body 21, and the outer surfaces31 of the faces 83 may contact the vertebral body walls 23. In otherembodiments, the sides of the sheet of barrier material 37 may bepositioned so as to be free of contact with the interior of the boneinto which it is delivered. With the sheet of barrier material 37 of thebone barrier device in a desired position, the distribution of bonefiller material injected into the interior of the vertebral body 21 canbe guided and/or controlled. In this manner, the sheet of barriermaterial 37 can prohibit substantially all flow of bone filler materialfrom the inner surface 32 (inside) of the material 37 of the deployeddevice 13 to the outer surface 31 of the material 37. In this manner,the device 13 can help prevent leakage of bone filler material through acompromised bone adjacent the barrier material 37.

In an embodiment, the sheet of barrier material 37 can comprise an openweave pattern adapted to reduce, but not necessarily stop, the flow ofbone filler material from the inner surface 32 to the outer surface 31of the device 13. For example, the sheet of barrier material 37 maycomprise an open weave, mesh, and/or through hole configuration that issufficiently fine to contain most of the flowable bone cement injectedinside the barrier material 37 to prevent leakage outside the vertebralbody 21 and still allow enough bone cement to penetrate the barriermaterial 37 so as to form a bond with the adjacent cortical bone 24.

In certain embodiments, the barrier material 37 can be a contiguoussheet of material. The barrier material 37 can comprise Teflon®,Dacron®, or similar biocompatible material. In some embodiments, the top81, bottom 82, and/or faces 83 of the sheet of barrier material 37 ofthe bone barrier device 13 can comprise a barrier material that canallow flow of fluids and nutrients through the material.

In some embodiments, the sheet of barrier material 37 can comprise oneor more sides of the bone barrier device 13. As such, the bone barrierdevice 13 can be utilized to selectively restrict movement of a flowablematerial in various directions. By restricting the area into which aflowable material can move while being injected and cured, spread of theflowable material out of a void or bony structure, such as through astructurally compromised endplate 22 and/or vertebral body side wall 23,into undesired areas can be minimized or prevented.

In various embodiments of a such a six-sided bone barrier device 13,from one to five sides of the device 13 can be open (without barriermaterial 37), all sides can be open, or no sides can be open. An openside of the bone barrier device 13 can be oriented toward a portion of abony structure, such as a vertebral body wall 23, so that when bonecement is injected into the void inside the vertebral body 21, the bonecement can flow into contact with the vertebral body wall 23 adjacentthe open side. In this manner, the bone cement can “interdigitate” withthe cortical bone 24 in the exposed wall 23 of the vertebral body 21 toform a bond with the bone 24, thereby providing a more stable support tothe vertebral body 21.

In embodiments in which one to five sides are open without barriermaterial 37, the bone barrier device 13 can be oriented so that openside(s) are facing compromised portion(s) of the endplate(s) 22 and/orvertebral body wall(s) 23 so as to contain flowable bone cement when itis injected into the void inside the vertebral body 21. In embodimentsin which no sides are open, bone cement can be prevented from contactingany cortical bone 24 surface inside the vertebral body 21. Although inembodiments with no open sides the bone cement cannot form a bond withcortical bone 24, the presence of the cured bone cement can providestructural support to the vertebral body 21. Embodiments of a totallyclosed-sided bone support device 13 may be desirable in a procedure torepair a vertebral compression fracture in which the endplates 22 and alarge portion of the vertebral wall 23 are compromised and there is riskof bone cement leakage from multiple locations about the vertebral body21.

In certain embodiments, the bone support and/or barrier device 13comprising a sheet of barrier material 37 may have less than six sides.For example, the bone support and/or barrier device 13 may have from oneto five sides. In each of the embodiments of the device 13 having fromone to six sides, the sheet of barrier material 37 can provide amechanism by which the distribution of bone filler injected into oradjacent the barrier material 37 can be guided and/or controlled.

During a procedure to repair a vertebral compression fracture, bonefiller material, such as a bone cement, may be inserted into thevertebral body 21 to provide structural support to the vertebral body21. In situations in which the fracture compromises the integrity of theendplate 22 or the wall 23 of the vertebral body 21, there may be a riskthat the bone cement can leak from the compromised bone. Bone cementleakage can produces symptoms, including painful irritation of a nerveroot emerging from the spinal column, degeneration of the walls of majorvessels, and possibly degeneration of the compromised endplate(s) 22.Thus, some embodiments of the bone support and/or barrier device 13 ofthe present invention can provide the advantage of preventing leakage ofbone cement into undesired areas.

As shown in FIGS. 15-17, the top 81, bottom 82, and four rounded faces83 of the six-sided bone support and/or barrier device 13 can be formedabout an implantable frame 80. The frame 80 can be configured such thatthe faces 83 can be generally perpendicular to the top 81 and the bottom82 of the device 13. The frame 80 can include a plurality of framemembers 84. Each of the members 84 can be connected at each end to twoother of the frame members 84 at joints 85 between the sides. In someembodiments, the barrier material 37 can be a contiguous sheet ofmaterial connected to the frame members 84. In other embodiments, aseparate sheet of the barrier material 37 can be attached to one or moresides of the device 13.

In some embodiments, the bone support and/barrier device 13 can bepositioned inside the bone into which it is delivered so that when theframe 80 is in its fully deployed position, the sheet of barriermaterial 37 can be free of contact with the bone. In other embodiments,in the fully deployed configuration, the outer surface 31 of at leastone side of the frame 80 can contact the first bone portion 35 inside abony structure, and the outer surface 31 of at least another side cancontact the second portion 36 of the bone so as to provide support tothe first bone portion. For example, the outer surfaces 31 of the top 81and bottom 82 of the frame 80 can be positioned in contact with thesuperior and inferior endplates 22 in a vertebral body 21, and the outersurfaces 31 of the faces 83 can contact the vertebral body walls 23. Assuch, the axial load 34 placed on the endplate 22 can be transferredfrom the endplate 22 through the frame 80 to the vertebral body walls23, thereby providing support to the endplate 22. In each of theseembodiments, the sheet of barrier material 37 can provide a mechanism bywhich the distribution of bone filler injected into or adjacent thebarrier material 37 can be guided and/or controlled.

In some embodiments, the frame members 84 on at least opposing sides ofthe frame 80 can include pivot joints 86 near the center of the framemembers 84. The pivot joints 86 allow the frame members 84 to pivot atthe pivot joints 86 so as to allow the bone support device frame 80 tobe collapsed to an undeployed configuration. For example, as shown inFIG. 17, in an embodiment in which the frame members 84 on opposite endsof the frame 80 include pivot joints 86, exerting a force on those framemembers 84 can cause the top and bottom portions of those frame members84 to pivot about the pivot joints 86 and fold into a generally parallelrelationship with each other. As a result, the ends of the frame 80having the pivot joints 86 can be collapsed so that the top 81 andbottom 82 of the frame 80 are adjacent each other. The frame members 84on the ends of the top 81 and bottom 82 of the frame 80 (which includepivot joints 86) can be pivoted about those pivot joints 86 such thatopposite sides of those frame members 84 can be folded together.Pivoting the ends of the top 81 and bottom 82 of the frame 80 can causethe remaining non-adjacent sides to be collapsed adjacent each other. Asa result, the frame 80 can be collapsed into an undeployed configurationfor delivery into an interior body region. In addition, the pivot joints86 can provide the sides of the frame 80 with a sufficient degree offlexibility to allow the sides to conform to possibly uneven surfacesinside a void in a vertebral body 21.

In embodiments of the six-sided bone support and/or barrier device 13comprising an implantable frame 80, one or more sides of the frame 80and sheet of barrier material 37 can be open. In embodiments in whichall sides are open, the bone barrier device 13 includes no barriermaterial 37, and bone cement can flow into contact with all corticalbone 24 surfaces inside the vertebral body 21. In embodiments of atotally open-sided frame 80, the frame members 84 can provide support tothe endplates 22 as well as to the vertebral body walls 23.

Some embodiments of the bone support and/or barrier device 13 havingfrom one to six sides can be inserted into an interior body region suchas a vertebral body 21 via a minimally invasive technique. For example,the delivery cannula 11 having a hollow lumen can be percutaneouslyinserted to the interior 33 of the vertebral body 21. The bone supportand/or barrier device 13 can be releasably attached in an undeployedconfiguration to the distal end 16 of the elongate member 14. Theelongate member 14 and the attached bone support and/or barrier device13 can be inserted through the lumen of the delivery cannula 11 into thevertebral body 21. When the bone support and/or barrier device 13 is ina desired position in the vertebral body 21, the device 13 can bedeployed into a deployed configuration into contact with the endplate22, vertebral body walls 23, and/or other bony structures in thevertebral body 21. Then, the bone support and/or barrier device 13 canbe released from the elongate member 14, and the elongate member 14 anddelivery cannula 11 removed from the vertebral body 21.

The bone support and/or barrier device 13 can be expanded to a desireddeployed configuration using various apparatus and techniques. Forexample, some embodiments of the bone support and/or barrier device 13may be expanded into the deployed configuration with the expandable body17, such as an inflatable balloon tamp. The expandable body 17 can bepre-positioned inside the bone support and/or barrier device 13 anddelivered to the target bony structure at the same time the bone supportdevice 13 is delivered. Alternatively, the bone support and/or barrierdevice 13 can be first delivered to the target bony structure, afterwhich the expandable body 17 can be delivered through the deliverycannula 11 to inside the bone support and/or barrier device 13 in thetarget bony structure. From inside the bone support and/or barrierdevice 13, the expandable body 17 can be expanded to thereby expand thebone support and/or barrier device 13 to its deployed configuration.

In some embodiments, the expandable body 17 can be utilized to positionand/or orient the bone support and/or barrier device 13 in the bonystructure. For example, the bone support and/or barrier device 13 can bepartially expanded with the expandable device 17 and oriented into adesired position such that a closed side of the device 13 comprisingbarrier material 37 is facing the portion(s) of the surroundingstructures into which it is desired to prevent flow of a flowablematerial. The expandable device 17 can then be further expanded to fullydeploy the bone support and/or barrier device 13. With the bone supportand/or barrier device 13 in place, the expandable body 17 can bedeflated and removed. In other embodiments, the bone support and/orbarrier device 13 can be oriented to a desired position relative toareas within a bony structure in which it has been delivered in othermanners and using other apparatus. Once the device 13 is fully deployedand positioned, the device 13 can be released from the elongate member14. The void can then be filled with a flowable bone filler materialthrough the delivery cannula 11.

In some embodiments, the collapsed, undeployed bone support and/orbarrier device 13 can be covered with a sheath (not shown) duringdelivery through the delivery cannula 11 to the target site. Such asheath can help maintain the device 13 in its undeployed configurationduring delivery into the target bony structure. Once the bone supportand/or barrier device 13 is in position in the bony structure, thesheath can be removed from around the bone support and/or barrier device13 and retracted through the delivery cannula 11. When the sheath isremoved from about the bone support and/or barrier device 13 inside thetarget bony structure, the device 13 can be expanded to its deployedconfiguration.

In certain embodiments, the bone support and/or barrier device 13 cancomprise a shape memory material, such as Nitinol. The sheath can helpmaintain the device 13 comprising shape memory material in itsundeployed configuration during delivery into a target bony structure.When the bone support and/or barrier device 13 comprising a shape memorymaterial is delivered to the target site inside a sheath and the sheathis removed from the bone support and/or barrier device 13, the device 13can expand to it deployed configuration without further manipulation.That is, the normal temperature of the patient's body can warm the shapememory material sufficiently to cause the bone support and/or barrierdevice 13 to expand to its deployed configuration.

The bone support and/or barrier device 13 comprising the six-sided frame80 can include radiopaque markers 70, as shown in FIG. 17. Theradiopaque markers 70 can be arranged in a radiopaque marking patternthat can be configured to allow for radioscopically visualizing thepositioning and orientation of the device 13 in the interior bodyregion. For example, the radiopaque markers 70 can be arranged toprovide essentially an outline of one or more of the sides of the bonesupport and/or barrier device 13 when expanded. In this manner, the usercan directly monitor positioning of those sides of the bone supportand/or barrier device 13 relative to various portions of the bonystructure while deploying the device 13.

In certain embodiments, the bone support and/or barrier device 13comprising the frame 80 having one to six sides can be sized so as tospan across substantially all of a vertebral body endplate 22 when inits deployed configuration. Alternatively, the bone support and/orbarrier device 13 can be sized to span less than substantially all of anendplate 22 when fully deployed. In some embodiments, a plurality of thebone support and/or barrier devices 13 can be used together to providesupport to particular portions of the endplate 22 or other bonystructure(s).

FIGS. 18-20 illustrate another embodiment of the bone support and/orbarrier device 13 configured to guide and or control the distribution ofbone filler material injected into the interior of a bone. In thisembodiment, the bone support and/or barrier device 13 can comprise adisc 90 of material that can be deployed into the interior of a bone.“Disc” refers to the deployed configuration of the device 13, which canbe, for example, an oval 65, circular, semi-circular 68, dome 66,tubular, or U-shaped configuration. The disc 90 can have an outersurface 31 and an inner surface 32.

In some embodiments, the bone support and/or barrier device disc 90 cancomprise a barrier material 37 adapted to restrict flow of bone fillermaterial from the inner surface 32 to the outer surface 31 of the disc90 without providing any additional structural support to a bonystructure. That is, the barrier material 37 comprising the disc 90 canbe a flexible, non-rigid material. For example, the bone support and/orbarrier device disc 90 comprising pliable, non-rigid material can bedeployed adjacent a compromised area within a vertebral body 21, such asa fractured endplate 22, before filling a void in the vertebral body 21with bone cement. In this manner, the bone barrier device disc 90 canhelp support the integrity of such a compromised bony structure byhelping prevent leakage of bone cement from the vertebral body 21.

In some embodiments, the bone barrier device 13 may be deployed suchthat the disc 90 contacts no portion of bone. For example, when the bonebarrier device 13 is deployed inside the vertebral body 21, the disc 90may be positioned such that the disc 90 material is free from contactwith the endplates 22 and/or the vertebral body walls 23.

In other embodiments, the bone barrier device 13 may be deployed suchthat the disc 90 can contact the first portion of bone 35 and/or thesecond portion of bone 36. For example, the bone barrier device 13 maybe deployed into a position such that a portion of the outer surface 31of the disc 90 may contact the vertebral body endplate 22 (that is, thefirst bone portion 35). The perimeter 91 of the bone barrier device disc90 can extend away from the endplate 22. In an embodiment, the perimeterof the disc 90 can contact the cortical bone 24 of the vertebral bodywalls 23 (that is, the second bone portion 36), which may help maintainthe device 13 in a desired position.

In an alternative embodiment, the disc 90 can comprise a sufficientrigidity such that the axial load 34 placed on the first portion of thebone (endplate 22) can be transferred through the bone support devicedisc 90 to the second portion of the bone (vertebral body walls 23),thereby providing support to the first bone portion (endplate 22).

Embodiments of the bone barrier device disc 90 can have various deployedconfigurations. For example, the deployed disc 90 configuration can beoval 65, circular, semi-circular 68, dome 66, tubular, or U-shapedconfiguration. In an embodiment in which the bone support and/or barrierdevice disc 90 comprises a tubular shape, the disc 90 can be orientedsuch that opposing sides of the tubular disc 90 can contact the superiorand inferior endplates 22 in the vertebral body 21. Such a bone supportand/or barrier device disc 90 having oppositely oriented sides may bedesirable for use in a vertebral body 21 in which both superior andinferior endplates 22 are compromised.

Some embodiments of the bone support and/or barrier device 13 may bepermanently implanted in the interior of a bone. In embodiments in whichthe bone support and/or barrier device disc 90 can be left permanentlyin place, the device 13 can be made from biocompatible materials such asstainless steel, a flexible metal alloy such as Teflon®, and/or shapememory materials such as Nitinol. In other embodiments, the bone supportand/or barrier device disc 90 may be made from bioresorbable materials,such as bioresorbable polymers, such that the device 13 can eventuallyresorb into the surrounding tissue.

The disc 90 material can comprise a barrier material 37 adapted toprohibit substantially all flow of bone filler material from the innersurface 32 of the disc 90 of the deployed device to the outer surface 31of the disc 90. In this manner, the device 13 can help guide and orcontrol the distribution of bone filler material as it is injected intoa void in the bone and prevent leakage of the bone filler materialthrough a compromised bony structure adjacent the disc 90. In anembodiment, the barrier material 37 can comprise an open weave patternadapted to reduce, but not necessarily stop, the flow of bone fillermaterial from the inner surface 32 to the outer surface 31 of the device13. For example, the barrier material 37 may comprise an open weave,mesh, and/or through hole configuration in which the open area issufficiently fine to contain most of the flowable bone cement injectedadjacent the inner surface 32 of the disc 90 to prevent leakage outsidethe vertebral body 21 and still allow enough bone cement to penetratethe barrier material 37 so as to form a bond with the surface of thecortical bone 24 adjacent the outer surface 31 of the disc 90. In someembodiments, the barrier material 37 can have a porosity sufficient toallow nutrients to diffuse through the barrier material 37. The barriermaterial 37 can comprise Teflon®, Dacron®, or similar biocompatiblematerial.

Some embodiments of the bone support device and/or barrier disc 90 canbe inserted into an interior body region such as a vertebral body 21 viaa minimally invasive technique. For example, the delivery cannula 11having a hollow lumen can be percutaneously inserted to the interior ofa vertebral body 21. The bone support and/or barrier device disc 90 canbe releasably attached in an undeployed configuration to the distal end16 of the elongate member 14. The elongate member 14 and the attachedbone support and/or barrier device disc 90 can be inserted through thelumen of the delivery cannula 11 into the vertebral body 21. When thebone support and/or barrier device disc 90 is in a desired position inthe vertebral body 21, the disc 90 can be deployed into a deployedconfiguration, for example, into no contact with bone, or into contactwith the endplate 22, vertebral body walls 23, and/or other bonystructures in the vertebral body 21. Then, the bone support and/orbarrier device disc 90 can be released from the elongate member 14, andthe elongate member 14 and delivery cannula 11 removed from thevertebral body 21. With the bone support and/or barrier device disc 90in a desired position, for example, adjacent the target endplate 22, abone filler material can be injected into the void in the vertebral body21 adjacent the inner surface 32 of the disc 90. The bone support and/orbarrier device disc 90 can thus provide a barrier to restrict flow ofthe bone filler material through a compromised endplate 22 and intoundesired areas.

An embodiment of the bone support and/or barrier device disc 90 can havean undeployed configuration that can be wrapped about the elongatemember 14, as shown in FIG. 18. Expansion of the expandable body 17inside the wrapped disc 90 can cause the disc 90 to unwrap to itsdeployed configuration, as shown in FIGS. 19 and 20.

In some embodiments, the bone support and/or barrier device disc 90 canbe adapted so that the outer surface 31 of the disc 90 can beselectively oriented toward a desired portion of a bone. In certainembodiments, the expandable body 17 can be used to orient the disc 90into various positions within the bone. For example, the bone supportand/or barrier device disc 90 can be partially expanded with theexpandable device 17 and rotated, or otherwise oriented, such that theouter surface 31 of the disc 90 is adjacent a compromised endplate 22 orvertebral body wall 23. The expandable device 17 can then be furtherexpanded to fully deploy the bone support and/or barrier device disc 90.With the disc 90 in place, the expandable body 17 can be deflated andremoved. In other embodiments, the bone support and/or barrier devicedisc 90 can be oriented to a desired position relative to areas within abony structure in which it has been delivered in other manners and usingother apparatus. Once the disc 90 is fully deployed and positioned, thedisc 90 can be released from the elongate member 14. The void can thenbe filled with a flowable bone filler material through the deliverycannula 11. In this way, a user can selectively guide and or controldistribution of bone filler material within a bony structure and/orhelping prevent leakage of bone filler material from a weakened orcompromised area.

In certain embodiments, the bone barrier device disc 90 can be sized soas to span across substantially all of a vertebral body endplate 22 whenin its deployed configuration. Alternatively, the bone barrier devicedisc 90 can be sized to span less than substantially all of the endplate22 when fully deployed. In some embodiments, a plurality of the bonebarrier device discs 90 can be used together to guide and or controldistribution of bone filler material within a bony structure.

During the process of expanding the expandable body 17 against acompromised bony structure, for example, in a vertebral body compressionfracture reduction procedure, the expandable body 17 may exert enoughpressure on the bony structure, such as the endplate 22, to initiate afracture or to extend an existing fracture. An embodiment of the bonesupport and/or barrier device 13 can be expanded with the expandablebody 17 against a compromised endplate 22. In this manner, the bonebarrier device disc 90 can provide a mechanism by which the distributionof bone filler material injected into the bony structure can be guidedand/or controlled. As a result, leakage of the bone cement through thecompromised endplate 22 can avoided.

The present invention may provide a system useful for supporting a bonystructure in a human or animal. An embodiment of such a system 10 cancomprise the delivery cannula 11 having a hollow lumen that can bepercutaneously inserted into an interior of a bone, and an elongatemember 14 insertable through the lumen of the delivery cannula 11. Animplantable bone support and/or barrier device 13 comprising an outersurface 31 and an inner surface 32 can be releasably attached to thedistal end 16 of the elongate member 14 in an undeployed configuration.Some embodiments of the system 10 can further comprise a deploymentmechanism that can be inserted through the lumen of the delivery cannula11 and actuated to deploy the bone support and/or barrier device 13 intoa deployed configuration in the interior of the bone. Some embodimentsof the system 10 can further comprise a release mechanism adapted torelease the bone support and/or barrier device 13 from the elongatemember 14.

In such an embodiment of a system 10, in the deployed configuration, atleast a first portion of the bone support and/or barrier device 13 cancontact a first portion of the bone, such as a vertebral body endplate22. A second portion of the bone support and/or barrier device 13 cancontact a second portion of the bone, such as vertebral body walls 23.In this manner, the axial load 34 placed on the first bone portion canbe transferred through the device 13 to the second bone portion, therebysupporting the first bone portion.

In some embodiments of a bone support system 10, the deploymentmechanism can comprise the expandable body 17 adapted to be disposedinside the bone support and/or barrier device 13 and to expand thedevice 13 into the deployed configuration. In certain embodiments, thedeployment mechanism can include a sheath (not shown) covering thedevice 13 in the undeployed configuration such that the sheath can beremoved to uncover the device 13 for deployment into the deployedconfiguration.

In some embodiments of a system 10, the bone support and/or barrierdevice 13 can have a barrier material 37 attached to the device 13. Thebarrier material 37 can be adapted to prohibit substantially all flow ofbone filler material from the inner surface 32 to the outer surface 31of the device 13. In this manner, the device 13 can help prevent leakageof bone filler material through a compromised bony structure adjacentthe barrier material 37. Alternatively, the barrier material 37 cancomprise an open weave, mesh, and/or through hole pattern adapted toreduce, but not necessarily stop, the flow of bone filler material fromthe inner surface 32 to the outer surface 31 of the device 13. In someembodiments, the barrier material 37 can have a porosity sufficient toallow nutrients to diffuse through the barrier material 37.

Some embodiments of the bone support system 10 can include a radiopaquemarking pattern in communication with components of the system 10. Forexample, a radiopaque marking pattern can be in communication with thedelivery cannula 11, the elongate member 14, the bone support and/orbarrier device 13, and/or other components of the system 10. Componentshaving a radiopaque marking pattern can be monitored fluoroscopicallyduring and after placement into an interior body region so as to guidethe component(s) into desired position(s).

Some embodiments of the bone support system 10 can include a pluralityof the bone support and/or barrier devices 13. Each of the devices 13can be positioned in the deployed configuration to support a separateportion of a bone.

The present invention can include embodiments of a kit useful forsupporting a bony structure in a human or animal. An embodiment of sucha kit can comprise the delivery cannula 11 having a hollow lumen thatcan be percutaneously inserted into an interior of a bone, and anelongate member 14 insertable through the lumen of the delivery cannula11. The kit may further include an implantable bone support and/orbarrier device 13 comprising an outer surface 31 and an inner surface 32that can be releasably attached to the distal end 16 of the elongatemember 14 in an undeployed configuration.

In such an embodiment of the system 10, in the deployed configuration,at least a first portion of the bone support and/or barrier device 13can contact a first portion of the bone, such as a vertebral bodyendplate 22. A second portion of the bone support and/or barrier device13 can contact a second portion of the bone, such as vertebral bodywalls 23. In this manner, the load 34 placed on the first bone portioncan be transferred through the device 13 to the second bone portion,thereby supporting the first bone portion.

Some embodiments of the kit can further comprise a deployment mechanismthat can be inserted through the lumen of the delivery cannula 11 andactuated to deploy the bone support and/or barrier device 13 into adeployed configuration in the interior of the bone. In some embodiments,the deployment mechanism can comprise the expandable body 17 adapted tobe disposed inside the bone support device 13 and to expand the device13 into the deployed configuration. In certain embodiments, thedeployment mechanism can include a sheath (not shown) covering thedevice 13 in the undeployed configuration such that the sheath can beremoved to uncover the device 13 for deployment into the deployedconfiguration. Some embodiments of a kit can further comprise a releasemechanism adapted to release the bone support and/or barrier device 13from the elongate member 14.

In some embodiments of a kit, the bone support and/or barrier device 13can have a barrier material 37 attached to the device 13. In otherembodiments, the bone support and/or barrier device 13 can comprise thebarrier material 37 without any other structural support elements. Thebarrier material 37 can be adapted to prohibit substantially all flow ofbone filler material from the inner surface 32 to the outer surface 31of the device 13. In this manner, the device 13 can help prevent leakageof bone filler material through a compromised bony structure adjacentthe barrier material 37. Alternatively, the barrier material 37 cancomprise an open weave, mesh, and/or through hole pattern adapted toreduce, but not necessarily stop, the flow of bone filler material fromthe inner surface 32 to the outer surface 31 of the device 13. In someembodiments, the barrier material 37 can have a porosity sufficient toallow nutrients to diffuse through the barrier material 37.

Some embodiments of a kit can include a radiopaque marking pattern incommunication with components of the kit. For example, a radiopaquemarking pattern can be in communication with the delivery cannula 11,the elongate member 14, the bone support and/or barrier device 13,and/or other components of the kit. Components having a radiopaquemarking pattern can be monitored fluoroscopically during and afterplacement into an interior body region so as to guide the component(s)into desired position(s).

Some embodiments of a bone support kit can include a plurality of thebone support and/or barrier devices 13. Each of the devices 13 can bepositioned in the deployed configuration to support a separate portionof a bone.

In some embodiments, a kit can comprise various combinations of theseand/or other components. For example, the kit may further includeadditional surgical instruments.

The present invention can include embodiments of methods for supportinga bone or bony structure in a human or animal. One embodiment of a sucha method 100, as illustrated in FIG. 21, can include percutaneouslyinserting (101) the delivery cannula 11 having a hollow lumen into theinterior of a bone. An embodiment of the method 100 can includeproviding (102) an implantable bone support and/or barrier device 13comprising an outer surface 31 and an inner surface 32. The bone supportdevice 13 can be releasably attached to the distal end 16 of theelongate member 14 in an undeployed configuration. The elongate member14 and attached bone support and/or barrier device 13 can be inserted(103) through the lumen of the delivery cannula 11 into the interior ofthe bone.

Once inside the bone, the bone support and/or barrier device 13 can bepositioned (104) in a desired location and/or orientation in the bone. Adeployment mechanism can be actuated (105) to deploy the bone supportand/or barrier device 13 into a deployed configuration. In someembodiment, in the deployed configuration, a first portion of the devicecan contact (106) at least a first portion of the bone from the interiorof the bone, and a second portion of the device can contact (107) atleast a second portion of the bone. In this manner, the load 34 placedon the first portion of the bone can be transferred (110) through thedevice 13 to the second portion of the bone, thereby providing supportto the first bone portion. The bone support and/or barrier device 13 canbe released (108) from the elongate member 14, and the elongate member14 can be removed (109) from the bone. In some embodiments, a bonefiller material can be inserted (111) adjacent the device 13 to providesupport to the bone.

In other embodiments of the method 100, the bone support and/or barrierdevice 13 may be percutaneously delivered to a target surgical siteusing a variety of techniques. For example, a small insertion cannula(not shown) having a sharp tip, for example, a trocar cannula, can beused to penetrate tissue to the surgical site. A guide wire (not shown)may be inserted through the insertion cannula. The insertion cannula canbe removed, leaving the guide wire in place. The elongate member 14 andattached bone support and/or barrier device 13 can then be guided overthe guide wire to the surgical site. When the bone support and/orbarrier device 13 is in a desired position, the guide wire can beremoved from the elongate member 14.

In some embodiments of the method 100, a plurality of the bone supportand/or barrier devices 13 can be provided. Each of the plurality of thedevices 13 can be deployed in a bone to support a separate portion ofthe bone.

In some embodiments of the method 100, the deployment mechanism cancomprise the expandable body 17. The expandable body 17, for example, aballoon bone tamp, can be expanded to, for example, move endplates 22 soas restore height to the vertebral body 21. The deployment mechanism canbe actuated so as to expand the expandable body 17 inside the bonesupport and/or barrier device 13 to expand the device 13 into itsdeployed configuration. In some embodiments, the deployment mechanismcan further include a sheath covering the device 13 in the undeployedconfiguration. The sheath can be removed to uncover the device 13 fordeployment into its deployed configuration.

In some embodiments of the method 100, the bone support and/or barrierdevice 13 can include a barrier material 37 attached to the device 13.The barrier material 37 can be adapted to prohibit substantially allflow of bone filler material from the inner surface 32 to the outersurface 31 of the device 13. When a bone filler material is insertedadjacent the inner surface 32 of the barrier material 37 of the bonesupport and/or barrier device 13, the bone filler material can beprevented from leaking outside an adjacent bony structure.

In an embodiment of the method 100, the bone support device 13 caninclude a central rod 40 pivotably attached about a pivot 43 to thedistal end 16 of the elongate member 14, as shown in FIGS. 4-6. Aplurality of support members 41 can be pivotably attached to the distalend 42 of the central rod 40 such that the support members 41 can beextended outwardly from the central rod 40. In such a method, actuating(105) the deployment mechanism can further include actuating the firstmechanism 51 to pivot the central rod 40 to an approximately 90 degreeangle relative to a longitudinal axis 52 of the elongate member 14. Thesecond mechanism 53 can then be actuated to extend the support members41 outwardly from the central rod 40 in a circular pattern. In this way,at least a portion of the outer surface 31 of the outwardly extendingsupport members 41 can contact (106) a first portion of the bone fromthe bone interior, and the distal ends 45 of the outwardly extendingsupport members 41 can contact (107) a second portion of the bone so asto provide support to the first bone portion.

The devices, systems, kits, and methods embodying the present inventioncan be adapted for use in many suitable interior body regions in humansand animals, wherever it may be desirable to provide support for atissue. The illustrative embodiments are described in association withdevices, systems, kits, and methods used to support bony structures. Forexample, the device can be utilized to provide structural support in avertebral body of a spine or in a joint. In other embodiments, thepresent invention may be used in other interior body regions or types oftissue.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include plural referents unless the contextclearly dictates otherwise. Thus, for example, the term “a supportmember” is intended to mean a single support member or a combination ofsupport members. For the purposes of this specification and the appendedclaims, unless otherwise indicated, all numbers expressing quantities,conditions, and so forth used in the specification are to be understoodas being modified in all instances by the term “about.” Accordingly,unless indicated to the contrary, the numerical parameters set forth inthe following specification are approximations that can vary dependingupon the desired properties sought to be obtained by embodiments of thepresent invention. At the very least, and not as an attempt to limit theapplication of the doctrine of equivalents to the scope of the claims,each numerical parameter should at least be construed in light of thenumber of reported significant digits and by applying ordinary roundingtechniques.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of embodiments of the invention are approximations, thenumerical values set forth in the specific examples are reported asprecisely as possible. Any numerical value, however, inherently containscertain errors necessarily resulting from the standard deviation foundin their respective testing measurements. Moreover, all ranges disclosedherein are to be understood to encompass any and all sub-ranges subsumedtherein. For example, a stated range of “1 to 10” should be consideredto include any and all sub-ranges between (and inclusive of) the minimumvalue of 1 and the maximum value of 10. That is, a stated range of “1 to10” should be considered to include, for example, all sub-rangesbeginning with a minimum value of 1 or more, such as 1 to 6.5, andending with a maximum value of 10 or less, such as 5.5 to 10.Additionally, any reference referred to as being “incorporated herein”is to be understood as being incorporated in its entirety.

Although the present invention has been described with reference toparticular embodiments, it should be recognized that these embodimentsare merely illustrative of the principles of the present invention.Those of ordinary skill in the art will appreciate that a bone supportdevice, system, kit, and method according to the present invention maybe constructed and implemented in other ways and embodiments. Inaddition, where methods and steps described above indicate certainevents occurring in a particular order, those of ordinary skill in theart having the benefit of this disclosure would recognize that theordering of certain steps may be modified and that such modificationsare in accordance with the variations of the invention. Additionally,certain of the steps may be performed concurrently in a parallel processwhen possible, as well as performed sequentially as described above.Accordingly, the description herein should not be read as limiting thepresent invention, as other embodiments also fall within the scope ofthe present invention.

1. A device, comprising: a structure implantable in a bone and having anouter surface, an inner surface, a first bone contact portion, and asecond bone contact portion, at least a portion of the outer surfacecomprising the first bone contact portion, the structure collapsible toan undeployed configuration capable of percutaneous insertion to theinterior of the bone and expandable to a deployed configuration in theinterior of the bone, wherein in the deployed configuration the firstbone contact portion contacts at least the first portion of the bonefrom the interior of the bone, and the second bone contact portioncontacts at least a second portion of the bone, and wherein a load onthe first portion of the bone is transferred through the structure tothe second portion of the bone.
 2. The device of claim 1, wherein thebone comprises a vertebral body, the first portion of the bone comprisesan endplate, and the second portion of the bone comprises a side wall ofthe vertebral body.
 3. The device of claim 1, wherein the bone comprisesa vertebral body, the first portion of the bone comprises a firstendplate, and the second portion of the bone comprises a second endplateopposite the first endplate.
 4. The device of claim 1, furthercomprising a barrier material attached to the structure adapted toprohibit substantially all flow of bone filler material from the innersurface to the outer surface of the structure.
 5. The device of claim 1,wherein the implantable structure further comprises: a central rod; anda plurality of support members extendable outwardly from an end of thecentral rod in a circular pattern.
 6. The device of claim 5, wherein thedeployed configuration further comprises the plurality of supportmembers extending outwardly in a dome shape, wherein at least a portionof an outer surface of the outwardly extending support members comprisesthe first bone contact portion, and wherein distal ends of the outwardlyextending support members comprise the second bone contact portion. 7.The device of claim 5, further comprising an elongate member having aproximal end and a distal end, wherein the central rod is pivotablyattached to the distal end of the elongate member and a handle isattached to the proximal end of the elongate member, and wherein thehandle comprises a first mechanism adapted to pivot the central rod toan approximately 90 degree angle relative to a longitudinal axis of theelongate member and a second mechanism adapted to extend the supportmembers outwardly from the central rod.
 8. The device of claim 7,further comprising a release mechanism adapted to release the centralrod from the elongate member.
 9. The device of claim 5, the implantablestructure further comprising at least two sets of the plurality ofsupport members, each set of support members capable of being deployedin a different direction in the interior of the bone.
 10. The device ofclaim 1, wherein the implantable structure further comprises a framecomprising an outer ring and a plurality of cross-members, eachcross-member extending across the outer ring, and wherein the pluralityof cross-members comprises the first bone contact portion and the outerring comprises the second bone contact portion.
 11. The device of claim10, wherein the deployed configuration further comprises a dome shape,and wherein the outer surface comprises a convex surface and the innersurface comprises a concave surface.
 12. The device of claim 10, whereinthe deployed configuration further comprises an essentially flat shape.13. The device of claim 10, wherein the cross-members are aligned in asubstantially parallel relationship, the undeployed configurationfurther comprising the outer ring and cross-members collapsed into anelongated configuration.
 14. The device of claim 10, each cross-memberpivotably intersecting with another cross-member, wherein the undeployedconfiguration comprises the cross-members collapsed about theintersections to a nearly parallel relationship, and wherein a forceexerted against an end of the collapsed cross-members moves the deviceinto a deployed configuration.
 15. A system, comprising: a deliverycannula having a hollow lumen and percutaneously insertable into aninterior of a bone; an elongate member insertable through the lumen ofthe delivery cannula; an implantable bone support device comprising anouter surface, an inner surface, a first bone contact portion, and asecond bone contact portion, the device releasably attachable to adistal end of the elongate member in an undeployed configuration; adeployment mechanism insertable through the lumen of the deliverycannula and actuatable to deploy the bone support device into a deployedconfiguration in the interior of the bone; and a release mechanismadapted to release the bone support device from the elongate member. 16.The system of claim 15, wherein in the deployed configuration the firstbone contact portion contacts at least a first portion of the bone fromthe interior of the bone, and the second bone contact portion contactsat least a second portion of the bone, and wherein a load placed on thefirst portion of the bone is transferred through the device to thesecond portion of the bone.
 17. The system of claim 15, furthercomprising a barrier material attached to the bone support deviceadapted to prohibit substantially all flow of bone filler material fromthe inner surface to the outer surface of the device.
 18. The system ofclaim 15, wherein the deployment mechanism further comprises anexpandable body adapted to be disposed inside the device and to expandthe device into the deployed configuration.
 19. The system of claim 15,wherein the deployment mechanism further comprises a sheath covering thedevice in the undeployed configuration, the sheath movable to uncoverthe device for deployment into the deployed configuration.
 20. Thesystem of claim 15, further comprising a radiopaque marking pattern incommunication with at least one of the delivery cannula, the elongatemember, and the bone support device.
 21. The system of claim 15, furthercomprising a plurality of the bone support devices, each of the devicespositionable in the deployed configuration to support a separate portionof the bone.
 22. A kit, comprising: a delivery cannula having a hollowlumen and percutaneously insertable into an interior of a bone; aelongate member insertable through the lumen of the delivery cannula;and an implantable bone support device comprising an outer surface, aninner surface, a first bone contact portion, and a second bone contactportion, the device releasably attachable to a distal end of theelongate member in an undeployed configuration.
 23. The kit of claim 22,wherein in the deployed configuration the first bone contact portioncontacts at least the first portion of the bone from the interior of thebone, and the second bone contact portion contacts at least a secondportion of the bone, and wherein a load placed on the first portion ofthe bone is transferred through the device to the second portion of thebone.
 24. The kit of claim 22, further comprising a barrier materialattached to the bone support device adapted to prohibit substantiallyall flow of bone filler material from the inner surface to the outersurface of the device.
 25. The kit of claim 22, further comprising adeployment mechanism insertable through the lumen of the deliverycannula and actuatable to deploy the bone support device into a deployedconfiguration in the interior of the bone.
 26. The kit of claim 24,further comprising a release mechanism adapted to release the bonesupport device from the elongate member.
 27. The kit of claim 22,further comprising a plurality of the bone support devices, each of thedevices positionable in the deployed configuration to support a separateportion of the bone.
 28. A method, comprising: providing an implantablebone support device comprising an outer surface, an inner surface, afirst bone contact portion, and a second bone contact portion, thedevice releasably attached in an undeployed configuration to a distalend of an elongate member; percutaneously inserting the elongate memberand attached bone support device into an interior of a bone; deployingthe bone support device into a deployed configuration; contacting atleast a first portion of the bone with the first bone contact portion;contacting at least a second portion of the bone with the second bonecontact portion such that a load placed on the first portion of the boneis transferred through the device to the second portion of the bone;releasing the bone support device from the elongate member; and removingthe elongate member from the bone.
 29. The method of claim 28, the bonecomprising a vertebral body, wherein contacting at least a first portionof the bone further comprises contacting an endplate with the first bonecontact portion; and wherein contacting at least a second portion of thebone further comprises contacting a side wall of the vertebral body withthe second bone contact portion.
 30. The method of claim 28, the bonecomprising a vertebral body having a first endplate opposite a secondendplate, wherein contacting at least a first portion of the bonefurther comprises contacting the first endplate with the first bonecontact portion, and wherein contacting at least a second portion of thebone further comprises contacting the second endplate with the secondbone contact portion.
 31. The method of claim 29, further comprisinginserting an expandable body into the bone interior, and expanding theexpandable body to restore height to the vertebral body.
 32. The methodof claim 28, further comprising injecting a bone filler materialadjacent the inner surface of the bone support device.
 33. The method ofclaim 28, wherein the bone support device further comprises a barriermaterial attached to the device and adapted to prohibit substantiallyall flow of bone filler material from the inner surface to the outersurface of the device.
 34. The method of claim 28, wherein deploying thebone support device further comprises expanding the expandable bodyinside the bone support device.
 35. The method of claim 28, wherein thebone support device further comprises a sheath covering the device inthe undeployed configuration, and wherein deploying the bone supportdevice further comprises removing the sheath from the bone supportdevice.
 36. The method of claim 28, the bone support device furthercomprising a central rod and a plurality of support members pivotablyattached to an end of the central rod, wherein deploying the bonesupport device further comprises: actuating a first mechanism to pivotthe central rod to an approximately 90 degree angle relative to alongitudinal axis of the elongate member; and actuating a secondmechanism to extend the support members outwardly from the central rodin a circular pattern, wherein at least a portion of an outer surface ofthe outwardly extending support members comprises the first bone contactportion, and wherein distal ends of the outwardly extending supportmembers comprise the second bone contact portion.
 37. The method ofclaim 28, further comprising providing a plurality of the bone supportdevices, and deploying each of the plurality of the devices to support aseparate portion of the bone.